BIOS Professional

GUDID 00057475696009

Disposable Face Masks, Box of 50

Thermor Ltd

Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use

• Primary Device ID: 00057475696009
• NIH Device Record Key: b1aa5c67-9d23-48be-8ddb-23a356639030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOS Professional
• Version Model Number: FS600
• Company DUNS: 246883458
• Company Name: Thermor Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00057475696009 [Primary]
GS1	10057475696006 [Package]; Package: Case [40 Units]; In Commercial Distribution

FDA Product Code

• QKR: Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-28
• Device Publish Date: 2023-09-20

Devices Manufactured by Thermor Ltd

• 10057475611016 - BIOS Living: 2024-05-31 Cervical Collar
• 10057475611023 - BIOS Living: 2024-05-31 Universal Arm Sling
• 20057475561011 - BIOS Living: 2024-04-01 Tapered Foam Ear Plugs 24 PC Blue 32dB
• 20057475561028 - BIOS Living: 2024-04-01 Tapered Foam Ear Plugs 16 PC Blue 32dB
• 20057475561035 - BIOS Living: 2024-04-01 Tapered Foam Ear Plugs 24 PC GREEN 32dB
• 20057475561042 - BIOS Living: 2024-04-01 Tapered Foam Ear Plugs 16 PC GREEN 32dB
• 20057475561059 - BIOS Living: 2024-04-01 Tapered Foam Ear Plugs 16 PC BLUE/WHITE TYE DYE 32dB
• 20057475561066 - BIOS Living: 2024-04-01 Shaped Foam Ear Plugs 16 PC ORANGE 32dB